- Takeda Pharmaceuticals (Boston, MA)
- … CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. ... CMC team, you will report to the Senior Manager GRA CMC and work with the...assigned projects (IND/ IMPD/ CTA/ MAA) according to the regulatory strategy laid out by GRA. +… more
- Actalent (Boston, MA)
- …deliverables including MW, regulatory and PV * Serve as point of contact/alliance manager for selected regulatory vendor(s) * Plan and execute regulatory ... & Responsibilities: * Manage submission-related activities o Working with Reg Dev and CMC leads, create content plans and submission timeline for regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about ... development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and… more
- Merck (Boston, MA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Takeda Pharmaceuticals (Boston, MA)
- …and accountable for overarching Global Program(s). The GPL defines the asset strategy and leads all development and Life Cycle Management projects associated with ... speed/cost to market (eg innovative trial designs, improving governance processes, asset strategy etc.) GPLs must + be experienced, versatile and strong enterprise… more